Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name surgeon's gloves
510(k) Number K964474
Device Name ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES
Applicant
ALLEGIANCE HEALTHCARE CORP.
1660 IOWA AVE., SUITE 100/200
RIVERSIDE,  CA  92507
Applicant Contact INGRID M HOOS
Correspondent
ALLEGIANCE HEALTHCARE CORP.
1660 IOWA AVE., SUITE 100/200
RIVERSIDE,  CA  92507
Correspondent Contact INGRID M HOOS
Regulation Number878.4460
Classification Product Code
KGO  
Date Received11/07/1996
Decision Date 03/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-